(188 days)
The TattooStar R is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are:
Lentigines, Café-au-lait-blotches, Ephalides, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.
The TattooStar R is a q-switched solid state lasers emitting wavelengths of 694 nm (Rubylaser). It consists a laser enclosure and optic delivery system (articulated mirror arm).
This 510(k) premarket notification for the TattooStar R device indicates that no nonclinical or clinical performance data was provided or required to demonstrate substantial equivalence.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria and reported device performance: No criteria were outlined, and no performance data was presented.
- Sample size and data provenance for the test set: No test set was used.
- Number of experts and their qualifications: No experts were involved in establishing ground truth for a test set.
- Adjudication method: Not applicable as there was no test set or expert review.
- MRMC comparative effectiveness study: Not conducted.
- Standalone performance study: Not conducted.
- Type of ground truth used: Not applicable as no ground truth was established for performance evaluation.
- Sample size for the training set: Not applicable as the device's performance was not evaluated through a training set.
- How ground truth for the training set was established: Not applicable.
The FDA's decision to clear the device was based on its substantial equivalence to a previously legally marketed predicate device, the RubyStar. This means the FDA determined that the TattooStar R has the same intended use, similar technological characteristics (same principle of operation, same wavelength), and raises no new questions of safety or effectiveness compared to the RubyStar, even though the RubyStar has a long-pulsed mode not present in the TattooStar R.
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SEP 2 7 2006
510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH TattooStar family
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH TattooStar family is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbHAm Semmicht 1A07755 Jena, Germany |
|---|---|
| Contact Person: | Mr Reinhard ThiemeQuality Assurance andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 77 00 251+49 3641 77 00 102reinhard.thieme@asclepion.com |
| Preparation Date: | June 18th, 2006 |
| Device Name: | TattooStar R |
| Common Name: | TattooStar R |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Device: | RubyStar |
| Device Description: | The TattooStar R is a q-switched solid state lasers emittingwavelengths of 694 nm (Rubylaser). It consists a laserenclosure and optic delivery system (articulated mirror arm). |
| Intended Use: | The TattooStar R is indicated of cutting, vaporization orablation of soft tissue. This includes tattoo removal andtreatment of benign pigmented lesions. |
| Comparison to: | The TattooStar R is substantially equivalent to the RubyStar,with the same principles of operation, and the sameindication for use ,the same wavelength but without a longpulsed mode which is used for hair removal. |
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Nonclinical Performance Data: None Clinical Performance Data: None Conclusion: The TattooStar R is another safe and effective device for the removal of tattoos and pigmented lesions and for ablation, cutting, vaporization of soft tissue for general dermatology. None
Additional Information :
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a human figure embracing a globe.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion Laser Technologies GmbH % Reinhard Thieme Quality Assurance Manager Arn Semmicht 1 A 07755 Jena. Germany
SEP 2 7 2006
Re: K060787
Trade/Device Name: TattooStar R Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 24, 2006 Received: August 28, 2006
Dear Reinhard Thieme:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Reinhard Thieme
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K060787
Device Name: TattooStar R
Indications for Use:
The TattooStar R is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are:
Lentigines, Café-au-lait-blotches, Ephalides, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number. K060787
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.